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Education/ExperienceBS in life sciences or related field At least 2 years experience in clinical researchKnowledge of FDA regulations Prior Study Start-Up experience preferredAdvanced skills in Microsoft Word, Microsoft PowerPoint, Microsoft Excel, Microsoft Outlook Experience with Adobe Acrobat Professional and Microsoft Access a plusPresentation Delivery ResponsibilitiesExecute study start-up for assigned protocols within company timelines by identifying clinical team needs, Oversee Site....


GLOBAL PHARMACEUTICAL COMPANY IS HIRING A HEAD OF MEDICAL AFFAIRS FOR RENAL Renal Cardio Medical Head (Executive Director) The Renal Cardio Medical Head is a member of the Renal-Cardio Therapeutic Area (RCTA) leadership team and leads the Renal Cardio Core Medical Team. The position can be either a Senior Director or Executive Director based upon the individual's experience. The Medical Lead is knowledgeable of the actions of regulatory bodies, in particular, knowledge of the FDA. He/She has....


Global Specialty Pharmaceutical company in Bridgewater, New Jersey is looking to hire a Manager of Clinical Quality AssuranceThe Manager Clinical Quality Assurance is a key member of the company Research and Development organization. This role is responsible for Clinical QA activity related to the planning, conduct, and reporting of GCP audits in order to ensure that clinical studies are conducted in compliance with applicable regulations, guidelines and company standards. This role also has....


Three Medical Directors needed The Medical Director is a board-certified physician who has a history of clinical practice, and has significant experience in the cardio therapeutic area, Endocrinology or Renal, Nephrology therapeutic areas. The Medical Director is knowledgeable of the actions of regulatory bodies, in particular FDA, and has experience in clinical trials. An ideal candidate should have significant experience in renal cardio disease management and would thrive on proactively....


The Director/Sr. Director of Clinical Development Operations is responsible for clinical operations planning, oversight and execution of multiple studies within one or more clinical development programs. Strategic development and coordination of operational approaches, guiding study level staff, and optimizing vendor performance. Sophisticated internal (cross functional team members) and external (KOLs, site staff) stakeholder communication and interface. Manage and/or mentor Clinical Trial....


Leading Global Pharmaceutical company with office in Waltham Massachusetts Manager, Health Economics & Outcomes Research (HEOR) Position Summary: The Manager for Health Economics & Outcomes Research (HEOR), will be responsible for supporting HEOR activities for company's products. This individual will contribute to evidence generation, development of strategy, data analysis and dissemination and support the HEOR Senior team members (Directors, Senior Directors).....

- Bridgewater, NJ

The CTM will work closely with the Director, Clinical Operations and Clinical Development team on the design, execution and oversight of clinical trials (all clinical phases) related to pharmaceutical product development and registration. The CTM is responsible for the overall operational planning and activities for the implementation and conduct of studies (clinical trials, IIT studies, compassionate use and registries) including data management activities, ensuring that clinical studies are....


Preferred Qualifications: · Clinical experience in or outside the US · Infectious Disease training with clinical and/or research background. · Knowledge of vaccine trial design and marketing issues. · The ideal candidate would be someone recognized by other vaccine experts as being expert in vaccinology or a related discipline. An acceptable candidate will have achieved recognition as highly experienced in relevant matters, e.g. infectious diseases, public health, clinical trials, etc. · The....


Represents Regulatory Affairs for pharmaceutical development projects and marketed products. Responsible for development and communication of all aspects of global regulatory strategy on R&D project teams. Leads team of regulatory professionals to assure successful planning and completion of regulatory activities on a worldwide basis. Responsible for knowledge of regulatory requirements of major regions (e.g. US, EU JP) with responsibility for working with colleagues on a worldwide basis....


Clinical Research Physician Global Oncology Pharmaceutical company is expanding and looking to add an MD Strong base salary and benefits and long term incentives POSITION OBJECTIVE: The Clinical Research Physician will be dedicated to providing a leadership role on a matrix team dedicated to stage appropriate clinical development of multiple innovative compounds. He or she will lead the development of clinical strategies for compounds and drive their successful implementation. Essential Job....

- Cambridge, MA

Global Company is hiring a Senior Leader Clinical Operations Biotechnology company specializing in the detailed structural analysis of complex drugs and is headquartered in Cambridge, MA. Company is applying its technology to the development of generic versions of complex drugs, biosimilar and potentially interchangeable biologics, and to the discovery and development of novel therapeutics for oncology and autoimmune indications This position will be responsible for initiating and leading....


The Senior Manager, Clinical Development CNS will participate in internal process improvement activities within R&D and Clinical Development. Main Areas of Responsibilities supports the Clinical Program Lead and Clin.Sci. Lead in the development of the Clinical Development Plan and associated clinical trial content (e.g., protocols, IBs/IDFUs, CRFs, CSRs, regulatory submissions and publications) by contributing to scientific/clinical information aligned with the strategy. key Clinical....

- Cranford, NJ

Global Pharmaceutical company is hiring a \ for their growing company. Our Clinical Trainer is responsible for identifying and implementing Clinical Development staff training needs. They may benchmark Clinical SOPs and insure SOP training is completed and up to date. The Clinical Operations Trainer may also periodically co-monitor and evaluate staff performance and provide guidance for performance, improvement and adherence to FDA and SOP requirements. They may liaise with US and Taiwan....

- Cambridge, MA

Exciting science being performed at this Pharmaceutical company. Looking to hire two Clinical Operations Leaders under the direction of the New Vice President Clinical.he Clinical Operation Lead is responsible for developing operational strategy for one or more clinical studies, and leading the cross functional Study Management Team to align and deliver on study goals of data quality, timelines, budget and GCP compliance in support of overall program level plans. Responsibilities: The Clinical

- Waltham, MA

Medical director - new products (depending on experience – may be senior or executive position) Reporting to VP & Head of Medical Affairs NA Staff responsibility Potentially yes Employment type Full time Purpose As a member of the NA medical affairs team this person will provide state of the art medical expertise and medical leadership for New Products Essential Responsibilities Lead the NA medical strategy and provide medical leadership and contribution for New ProductsProvide subject....


The Global Regulatory Team Lead (GRTL) is a Director-level role which is part of the Global Regulatory Affairs (GRA) team based in the US. This position is in Irvine, CA and is part of the Global Strategy team. He/she is responsible for developing long- and short-term regulatory strategies that impact company’s business objectives. Specific responsibilities include: Global Regulatory Team Lead (GRTL) is responsible for developing global regulatory strategy for projects in his/her remit, which....

- Irvine, CA

The candidate is responsible for expeditiously developing and processing raw material and product documentation to meet quality requirements within timelines established for product launch and/or timely project completion.The Master Specifications and Documentation department interacts with various Pharmaceutical groups within the organization and departments such as Quality, Global Pharmaceutical Technology, Regulatory Affairs, Operations, Manufacturing (all sites), Procurement (Sourcing),....


Plant Quality Manager -- Dairy Product Manufacturing -- SQF -- Excellent Salary, Benefits and relocation assistance This opportunity is with one of our finest client companies. We have placed many people with this firm over the years who have found an unexcelled career opportunity here. Continuous expansion, another new plant opened recently, very much in demand traditional food products! GENERAL DESCRIPTION of the Quality Manager position: The Plant Quality Manager oversees all Quality....


The Associate will be responsible for supporting CTM/OSL and ensuring that all assigned clinical study(ies) are running on time and on budget and are completed in compliance with all relevant laws, regulations, and regulatory guidelines as well as all policies and procedures. Requirements: Bachelor’s degree or higher (science degree preferably in science or health-related field) Previous experience of working on a clinical study 1-2 year relevant experience in pharmaceutical industry or CRO....


Job Title: Specialty Pharmacy Director Location: Baltimore, MD PRINCIPAL ACCOUNTABILITIES: The position reports directly to the Senior Director of the Pharmacy Evaluation & Oversight and is a critical leadership position within the unit responsible for understanding the specialty marketplace, opportunities for utilization management, and cost containment. The Director of Specialty Pharmacy will interact frequently with the EVP of Medical Affairs, the CEO, and other senior leaders across....

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